netFormulary South East London Joint Medicines Formulary NHS
Guy's and St Thomas' NHS Foundation Trust
Kings College Hospital NHS Foundation Trust
Lewisham and Greenwich NHS Trust
 
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 Formulary Chapter 1: Gastro-intestinal system - Full Chapter
01.05.03  Expand sub section  Drugs affecting the immune response
Anti-MAP (mycobacterium avium paratuberculosis) therapy (clarithromycin, rifabutin and clofazimine)

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Formulary
Red
Specialist gastroenterology use only

Follow local guidelines for use at GSTT

Patient Information Leaflet available on GTi (GSTT intranet)


Last line option for Crohn's disease patients who have not responded to/have been intolerant of or have a contraindication to treatment options and strategies for Crohn’s disease outlined within the SEL IBD Pathways (including immunosuppressants and biologics) and do not wish to have surgery.

Regimen:
  • Clarithromycin 250 mg each morning and 500 mg at night
  • Rifabutin 150 mg daily for 1 week, then 150 mg twice daily.
    If >50kg the dose may be increased to 450mg total daily dose
  • Clofazimine 100 mg daily (unlicensed product)

    The maximum treatment duration is 2 years

  • Link  SE London APC recommendation: Clofazimine in combination with clarithromycin and rifabutin as anti-MAP (Mycobacterium avium subspecies paprtuberculosis) therapy for the treatment of Crohn’s disease in adults    
    Cytotoxic Drug  Azathioprine tablets (inflammatory bowel disease - off-label)

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    Formulary
    Amber 3
    Approved off-label indication:
    Resistant or frequently relapsing inflammatory bowel disease

    Dose: 2 mg/kg daily

    For shared care arrangements, see guideline below

    Link  SE London APC Shared Care Agreement: Azathioprine and Mercaptupurine in Inflammatory Bowel Disease    
    Ciclosporin injection (ulcerative colitis - off-label)

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    Formulary
    Red
    Approved off-label indication:
    Severe acute ulcerative colitis refractory to corticosteroid treatment.

    Dose: 2 mg/kg over 24hours and dose adjusted according to blood-ciclosporin concentration and response
       
    Cytotoxic Drug  Mercaptopurine tabs (IBD - off-label)

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    Formulary
    Amber 3
    Approved off-label indications:
  • Severe acute inflammatory bowel disease (IBD)
  • Maintenance of remission of IBD

    For shared care arrangements, see guideline below

  • Link  SE London APC Shared Care Agreement: Azathioprine and Mercaptupurine in Inflammatory Bowel Disease    
    Cytotoxic Drug  Methotrexate tablets (Crohn’s disease - off-label)

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    Formulary Approved off-label indication:
    Crohn’s disease

    Dose 15-25 mg weekly
       
    Tacrolimus (Adoport®) (IBD - off-label)
    (Prescribe by brand)

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    Formulary
    Red
    Approved off-label indication:
    Refractory Crohn’s disease or ulcerative colitis, in patients who have failed or are contraindicated to all other conventional immunosuppressant and biological treatments.
       
    Tioguanine tabs (IBD - off-label)

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    Formulary
    Red
    Approved off-label indication:
    3rd line oral immunosuppressive agent for maintaining remission in adult patients with Crohn’s disease and ulcerative colitis
  • For use in patients who are intolerant or unresponsive to both azathioprine and mercaptopurine
  • Hospital prescribing and supply only
  • Dose: 20 mg to 40 mg daily

  • Link  SE London APC recommendation: Tioguanine for the treatment of adults with inflammatory bowel disease    
    Tacrolimus ointment (perianal Crohn’s disease - off-label)

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    Formulary Approved off-label indication:
    Ulcerating perianal Crohn’s disease and pyoderma gangrenosum as a last-line option if all other therapies and surgery have failed or are unsuitable
       
    01.05.03  Expand sub section  Cytokine inhibitors
    Adalimumab injection (IBD)

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    Formulary
    High Cost Medicine
    Red
    Approved as per NICE technology appraisal guidance

    Link  NICE TA187: Infliximab and adalimumab for the treatment of Crohn’s disease
    Link  NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy    
    Infliximab injection (IBD)

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    Formulary
    High Cost Medicine
    Red
    Approved as per NICE technology appraisal guidance

    Biosimilar products available, to be prescribed by brand name. Contact pharmacy department for advice on brand for routine prescribing if unsure

    Link  NICE TA163 Infliximab for acute exacerbations of ulcerative colitis
    Link  NICE TA187: Infliximab and adalimumab for the treatment of Crohn’s disease
    Link  NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy
    Link  SE London APC position statement: Biosimilar infliximab    
    Golimumab injection (ulcerative colitis)

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    Formulary
    High Cost Medicine
    Red
    Approved as per NICE technology appraisal guidance

    Approved off-label use:
    Increased dose of 100mg every 4 weeks in those <80kg who have had a partial response, or secondary loss of response to the 50mg dose

    Link  NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy    
    Ustekinumab injection (Crohn's disease)

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    Formulary
    High Cost Medicine
    Red
    Approved as per NICE technology appraisal guidance

    Link  NICE TA456: Ustekinumab for moderately to severely active Crohn’s disease after previous treatment    
    01.05.03  Expand sub section  Vedolizumab
    Vedolizumab injection

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    Formulary
    High Cost Medicine
    Red

    Link  NICE TA342 Vedolizumab for treating moderately to severely active ulcerative colitis
    Link  NICE TA352 Vedolizumab for treating moderately to severely active Crohn’s disease after prior therapy    
     ....
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    Section Title Section Title (top level) Non Formulary Item Non Formulary section
    Section Title Section Title (sub level)
    Cytotoxic Drug
    Cytotoxic Drug
    Restricted Drug
    Restricted Drug
    CD
    Controlled Drug
    Unlicensed Drug
    Unlicensed
    High Cost Medicine
    High Cost Medicine
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    Cancer Drugs Fund
       

     

    Traffic Light Status Information

    Status Description
      Red   Specialist Prescribing only. The responsibility for prescribing, monitoring, dose adjustment and review should remain with the specialist. In very exceptional circumstances a specialist may discuss individual patient need for a RED drug to be prescribed by a GP and the GP should consider informing the Medicines Management team before a decision is made to prescribe for individual patients.   
      Amber 1   Treatment can be initiated in primary care after a recommendation from an appropriate specialist  
      Amber 2   Specialist initiation followed by maintenance prescribing in primary care  
      Amber 3   Specialist initiation with ongoing monitoring required. After dose stabilisation GPs can be requested to take over prescribing responsibilities using the approved APC shared care documentation  
      Green   Specialist and non-specialist initiation  
      Grey   Not recommended for prescribing  

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